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Last Updated: August 12, 2020

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LEVITRA Drug Profile

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Which patents cover Levitra, and what generic alternatives are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has fifty-four patent family members in thirty-one countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Drug patent expirations by year for LEVITRA
Drug Prices for LEVITRA

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Drug Sales Revenue Trends for LEVITRA

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Recent Clinical Trials for LEVITRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tritech Biopharmaceuticals Co., Ltd.Phase 1/Phase 2
A2 Healthcare Taiwan CorporationPhase 1/Phase 2
Azienda USL ModenaPhase 2

See all LEVITRA clinical trials

Pharmacology for LEVITRA
Paragraph IV (Patent) Challenges for LEVITRA
Tradename Dosage Ingredient NDA Submissiondate
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-09-04
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-07-10
LEVITRA TABLET;ORAL vardenafil hydrochloride 021400 2009-03-05

US Patents and Regulatory Information for LEVITRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LEVITRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-001 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003   Start Trial   Start Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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